barzolvolimab for Urticaria

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
IMMUNOe Research Centers, Centennial, CO
Urticaria+4 More
barzolvolimab - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

The purpose of this study is to assess the clinical effect, the pharmacodynamics, the safety, and the pharmacokinetics of barzolvolimab (CDX-0159) in patients with Chronic Inducible Urticaria who remain symptomatic despite the use of H1-antihistamines.

Eligible Conditions

  • Urticaria
  • Chronic Inducible Urticaria

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Urticaria

Study Objectives

1 Primary · 7 Secondary · Reporting Duration: From baseline to week 20

Week 12
Change in provocation threshold and itch for ColdU
Change in provocation threshold for SD
Change in worst itch reported after provocation for ColdU
Change in worst itch reported after provocation for SD
Change in worst itch reported after provocation in both SD and ColdU
Combined patients with a negative provocation test at week 12
Percentage of patients with a negative provocation test at week 12
Week 20
Percentage of patients experiencing adverse events

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Urticaria

Trial Design

6 Treatment Groups

barzolvolimab 300 mg in patients with Symptomatic Dermographism
1 of 6
barzolvolimab 150 mg in patients with Symptomatic Dermographism
1 of 6
barzolvolimab 300 mg in patients with Chronic Inducible Cold Urticaria
1 of 6
barzolvolimab 150 mg in patients with Chronic Inducible Cold Urticaria
1 of 6
Placebo Comparator in patients with Symptomatic Dermographism
1 of 6
Placebo Comparator in patients with Chronic Inducible Cold Urticaria
1 of 6
Experimental Treatment
Non-Treatment Group

180 Total Participants · 6 Treatment Groups

Primary Treatment: barzolvolimab · Has Placebo Group · Phase 2

barzolvolimab 300 mg in patients with Symptomatic Dermographism
Biological
Experimental Group · 1 Intervention: barzolvolimab · Intervention Types: Biological
barzolvolimab 150 mg in patients with Symptomatic Dermographism
Biological
Experimental Group · 1 Intervention: barzolvolimab · Intervention Types: Biological
barzolvolimab 300 mg in patients with Chronic Inducible Cold Urticaria
Biological
Experimental Group · 1 Intervention: barzolvolimab · Intervention Types: Biological
barzolvolimab 150 mg in patients with Chronic Inducible Cold Urticaria
Biological
Experimental Group · 1 Intervention: barzolvolimab · Intervention Types: Biological
Placebo Comparator in patients with Symptomatic Dermographism
Drug
PlaceboComparator Group · 1 Intervention: Matching Placebo · Intervention Types: Drug
Placebo Comparator in patients with Chronic Inducible Cold Urticaria
Drug
PlaceboComparator Group · 1 Intervention: Matching Placebo · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from baseline to week 20
Closest Location: IMMUNOe Research Centers · Centennial, CO
Photo of colorado 1Photo of colorado 2Photo of colorado 3
2017First Recorded Clinical Trial
3 TrialsResearching Urticaria
21 CompletedClinical Trials

Who is running the clinical trial?

Celldex TherapeuticsLead Sponsor
57 Previous Clinical Trials
3,437 Total Patients Enrolled
3 Trials studying Urticaria
248 Patients Enrolled for Urticaria

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are willing and able to complete a daily symptom electronic diary and comply with study visits.
You have a diagnosis of chronic coldU or SD >/= 3 months.
You have a history of wheals with or without angioedema due to ColdU or SD for >/= 6 weeks at any time prior to Visit 1 despite the use of H1-antihistamines.
You are on a stable regimen of a second generation non-sedating H1-antihistamine for at least 4 weeks prior to study treatment and agree to stay on through trial.
The test should be performed within 10 minutes after using TempTest® at any temperature at both screening (Visit 1) and randomization (Visit 3).

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.